The FDA has approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer whose tumors are not able to be surgically removed and whose cancer has not progressed after treatment with chemotherapy and radiation.
FDA approves new treatment for a certain type of prostate cancer using novel clinical trial endpoint
FDA approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread, but that continues to grow despite treatment with hormone therapy. This is the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer.
Roche and Flatiron Health Inc. announced today that the two partners have signed a definitive agreement under which Roche will acquire all shares of Flatiron Health, following on from an existing equity stake of 12.6%. The transaction is expected to close in the first half of 2018.
Bristol-Myers Squibb Co. and Nektar Therapeutics executed a global strategic development and commercialization collaboration for Nektar's lead immuno-oncology program, NKTR-214. Under the collaboration, the companies will jointly develop and commercialize NKTR-214 in combination with BMS's Opdivo (nivolumab) and Opdivo plus Yervoy (ipilimumab) in more than 20 indications across nine tumor types, as well as potential combinations with other anti-cancer agents from either of the respective companies and/or third parties.
The United Kingdom's National Institute for Health and Care Excellence has published a Final Appraisal Determination recommending FOTIVDA (tivozanib) for the first line treatment of adult patients with advanced renal cell carcinoma.
FDA approved abiraterone acetate (Zytiga) tablets in combination with prednisone for metastatic high-risk castration-sensitive prostate cancer (CSPC). The drug is sponsored by Janssen Biotech Inc.
Foundation Medicine Inc. and the European Organisation for Research and Treatment of Cancer announced a collaboration in which Foundation Medicine's comprehensive genomic profiling tests will be used to inform patient eligibility for oncology clinical trials through the EORTC's Screening Patients for Efficient Clinical Trial Access program, which is a pan-European network built by the EORTC with key institutions collaborating to provide efficient access for patients to molecularly driven clinical trials.
ANGLE plc has signed an agreement with Abbott in which Abbott will supply ANGLE with its proprietary PathVysion HER-2 DNA FISH Probe kits for ANGLE's ANG-002 FDA study for FISH (fluorescence in situ hybridization) analysis of circulating tumor cells in the form of a research grant.
FDA has approved lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications USA, Inc.) a radiolabeled somatostatin analog, for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors in adults.
Amgen said the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending a label variation for Kyprolis (carfilzomib) to include updated overall survival data from the phase III head-to-head ENDEAVOR trial in patients with relapsed or refractory multiple myeloma (Kyprolis and dexamethasone versus Velcade [bortezomib] and dexamethasone).
